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Improving Patient Access to Biologics: Q&A with Melissa Paige (Part 2 of 2)

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Q: To what degree do you use manufacturer-sponsored support programs for FDA-approved poly ADP-ribose polymerase (PARP) inhibitors indicated for the treatment of advanced ovarian cancer?

A: We use the manufacturer hubs for all the PARP inhibitors. However, we carefully evaluate each hub service in advance to determine the value to our institution. It is important that each service fits into our processes and workflow when an oncologist has requested a certain PARP inhibitor.

Our use of the manufacturer hub also depends on the situation, based on our needs, which can vary from one patient to another. Some claims can be straightforward, and we navigate the access process ourselves. However, we may seek the manufacturer’s assistance for more complex requests.

Q: The oral PARP inhibitor niraparib (Zejula) recently received FDA approval as a first-line maintenance treatment for patients with advanced ovarian cancer. Would that be considered a complex request in the months postapproval?

A: Yes, it could be, depending on the health insurer. When drugs receive a new indication, it may take time before payers update their prior authorization requirements. There may be more rigorous documentation requirements when a drug is prescribed first-line, especially for a maintenance indication where the course of treatment is not strictly defined. Sometimes these requests require a first-level appeal, and we may reach out to the manufacturer’s reimbursement specialist to help us write a letter of medical necessity or to assist in navigating the appeal process, using the resources from the manufacturer to help justify the prescriber’s decision. While we await the approval, we investigate the patient’s financial assistance options to assess their cost-sharing requirements. Sometimes, we take advantage of the “quick-start” programs offered by manufacturers.

When we know that we are going to have to fight a bit more, it is good to know that the hub is there to support us.

Q: Several PARP inhibitors are indicated to treat advanced ovarian cancer. Are there any unique aspects regarding the access process for these drugs, or is it similar to the process used with other oral oncology agents?

A: The process is fairly similar. When PARP inhibitors were first approved, we encountered some issues in running the benefits investigations through manufacturers’ preferred specialty pharmacies. Initially, it was a challenge because Patient Assistance Program (PAP) applications were required to go through 1 designated specialty pharmacy, which was not apparent to us at the time. Now the process runs much more smoothly.

However, there are some differences in financial assistance program requirements for PARP inhibitors. In some cases, patients may not be able to afford the drug preferred by the physician. As a result, we sometimes help the patient apply to all the programs to see what the patient cost-sharing requirements will be for each option. If there is a big difference, we may go back to the prescriber to discuss patient affordability. In reality, this may affect which drug the patient receives.

Q: To what degree has your institution embraced technology solutions to facilitate patient access to biologics, including PARP inhibitors?

A: Many technology solutions have been introduced in the past few years in an effort to streamline the access process, and we are using them. Currently, CoverMyMeds is our main technology platform for electronic prior authorizations. We have recently started using Surescripts and CoverMyMeds for electronic benefits investigations, running them concurrently. Many, but not all, payers recognize one or the other and provide the benefits information electronically. Then, we answer all the prior authorization questions. We have pharmacists and nurses onsite to help with the clinical notes.

That said, not all our payers will accept electronic prior authorization requests. In some cases, we are still asked to fax them the forms.

Q: Are you using provider portals to access any of the manufacturer support programs?

A: Yes, to some degree. However, the main challenge we have faced is that the electronic process through the portals does not always fit into our workflow. If we have a defined process that works well for us, such as prior authorization, it becomes disruptive to try to change it.

We use the manufacturer portals for some services, but we need to retain control over the process. For example, we may want them to do the benefits check, but we want to decide which specialty pharmacy to send the prescription to.

Also, the setup process for a new portal can be very time-consuming. That can be a barrier, because each manufacturer has their own portal, and there are a lot of companies.

Q: How could the portal setup process be streamlined?

A: When setting up most of the portals, there is a great deal of information that must be entered manually. It would save us time if we could give the manufacturer a list of National Provider Identifiers and have them prepopulate the necessary demographic information for each of our sites. This way, it would match the same tax ID number.

Q: What do manufacturers need to think about as they refine services to access electronic processes through their portals? What are some of the things that they can do to make their programs more useful for oncology practices and clinics?

A: I am a huge advocate for portals when they meet our needs. We appreciate the financial assistance programs and often access those electronically. I would submit electronic prior authorizations through the portal as long as I had confidence that it worked properly. Our biggest barrier is that we do not know what happens when the prescription leaves our facility. If a portal could help us track the prescription, confirm that it was filled, and provide refill information to let us know that the patient was taking it properly, that would be huge for us. It would also be helpful to receive alerts when patients are due for a refill, so we could follow up.

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